An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial

Context  Data on the adverse effects of newly marketed drugs are limited. Voluntary reporting is an important part of postmarketing surveillance but is underused by physicians. Objective  To evaluate the effectiveness of educational outreach visits for improving adverse drug reaction (ADR) reporting by physicians. Design, Setting, and Participants  A cluster-randomized controlled trial covering all National Health System physicians in the north of Portugal, with intervention in March 2004 through July 2004, and 13 to 16 months of follow-up. A total of 1388 physicians were assigned in 4 spatial clusters to the intervention group, and 5063 were assigned in 11 clusters to the control group. Intervention  One-hour educational outreach visits tailored to training needs identified in a previous study. Main Outcome Measures  Change in total number of reported ADRs and number of serious, high-causality, unexpected, and new-drug-related ADRs, using generalized linear mixed models adjusted for baseline ADR reporting, age, specialty, and work setting. Results  At baseline, ADR reporting rates (per 1000 physician-years) did not differ significantly between the intervention groups and the control groups in reporting ADRs overall (7.6 vs 11.3), nor did they differ significantly by category: serious, 4.3 vs 6.0; high-causality, 5.4 vs 7.6; unexpected, 1.6 vs 3.5; and new-drug-related ADRs, 3.7 vs 3.8. (P>.05 for all comparisons). The control group had no significant increase in ADR reports during follow-up. The adjusted increase in ADR reporting rates attributable to intervention was 90.19 for total ADRs (95% confidence interval [CI], 54.51-125.87; relative risk [RR], 10.23; 95% CI, 3.81-27.51), 30.16 for serious ADRs (95% CI, 18.84-41.47; RR, 6.32; 95% CI, 2.09-19.16), 64.90 for high-causality ADRs (95% CI, 38.38-91.42; RR, 8.75; 95% CI, 3.05-25.07), 28.04 for unexpected ADRs (95% CI, 16.25-39.83; RR, 30.21; 95% CI, 4.54-200.84), and 42.17 for new-drug-related ADRs (95% CI, 21.58-62.76; RR, 8.05; 95% CI, 2.10 -30.83). The greatest difference occurred during the first 4 months after intervention, but differences remained statistically significant for 12 months. Conclusion  A targeted outreach program may improve high-quality reporting of ADRs among physicians.      

Erythema figuratum in septic babesiosis

Babesiosis is a rare worldwide-distributed protozoal zoonosis caused by a haemoprotozoan of the genus Babesia, transmitted through bites of tick of the genus Ixodes. The first demonstrated case of human babesiosis in the world was discovered in Europe, in 1957. However, most of the cases were reported later in the north-east of the United States where Babesia microti has been the cause of over 300 cases of human babesiosis since 1969. In Europe, the most severe cases are observed in asplenic patients infected by a parasite of cattle, the Babesia divergens. Only two cases of babesiosis have been reported in Spain. We present a case of erythema figuratum associated to septic babesiosis in a non-splenectomized man, which is currently the third case of babesiosis in Spain.     

Brain metastases from an unknown primary tumour: which diagnostic procedures are indicated?

Seventy two patients presenting with symptomatic brain metastases from undiagnosed primary neoplasms were retrospectively reviewed. Primary malignancies were diagnosed before death in 54 patients and remained unknown in 18 patients. Lung cancer was the most common primary tumour (72%), followed by breast cancer, colon carcinoma, and melanoma. On physical examination, 51 patients had organ specific symptoms or signs providing guidelines to the diagnostic evaluation. In 24 of the 52 patients with a primary lung tumour, and in four of the 20 patients without, organ specific complaints or findings suggested this tumour type, resulting in a positive predictive value of 85%. Overall, radiography and CT of the chest were very useful in detection of primary lung tumours. This could partly be explained by the high prior probability of detecting such tumours. Other diagnostic procedures should be used on indication only. The prognosis of patients with confirmed primary tumour position did not differ from those with unidentified primary tumour.     

Resection of the portal vein in pancreatectomy for cancer: technical considerations. Apropos of 4 cases]

Out of 150 carcinomas of the pancreas operated from 1970 through 1989, 50 pancreatectomies were performed, including 4 cases of segmental resection of portal vein with total pancreatectomy (2 cases) or duodenopancreatectomy (2 cases). The technical procedure is described and discussed. Segmental resection of portal vein is rare in our experience and has been always performed out of necessity because of the over estimation of the resectability. However, mortality and post-operative stay are not increased.     

The organization of pyramidal cells in area 18 of the rhesus monkey

The aim of this study was to investigate the vertical organization of axons and pyramidal cells in area 18, and to compare it with that in area 17. In area 18 there are regularly spaced vertical bundles of myelinated axons that have an average center-to-center spacing of 21 microns. This arrangement of axons resembles that in area 17. Pyramidal cells in area 18 and their apical dendrites are less regularly arranged. The apical dendrites of the pyramidal cells of layer 6A aggregate with those from layer 5 pyramids to form swathes of apical dendrites that pass into layer 4. There they are joined by the apical dendrites of the small layer 4 pyramids, so that much of the neuropil of layer 4 is occupied by apical dendrites. Most of these apical dendrites form their terminal tufts in layer 3. Very few of them reach layer 1, which is dominated by the apical dendrites of layer 2/3 pyramids. Thus, there are two tiers of apical dendrites and their apical tufts, a deep one formed by the layer 4, 5 and 6 apical dendrites that terminate in layer 3, and a second one formed by the apical dendrites of layer 2/3 pyramids that terminate in layer 1. In contrast, in area 17 the apical dendrites of layer 5 pyramids form discrete clusters that have a center-to-center spacing of 23 microns. These clusters are joined by the apical dendrites of the layer 2/3 pyramids and all of these apical dendrites form their apical tufts in layer 1. Based upon the dispositions of the apical dendrites of the pyramidal cells in area 17 and 18, we speculate that the influences of, and the interactions between, the feed-forward and feed-back signals in the two areas are quite different, because in the two areas different postsynaptic targets are available to these afferents.